Custom RX, LLC
Form 483 issued August 15, 2017 · Wichita, Kansas
- Inspection
- Jul 31 – Aug 15, 2017
- Investigator
- Rita K. Kabaso
- Observations
- 2
- Pages
- 2
- FEI number
- 3013444075
In short: On August 15, 2017, FDA issued a Form 483 with 2 observations to Custom RX, LLC in Wichita, Kansas (FEI 3013444075) after an inspection that ran Jul 31 – Aug 15, 2017. The investigator was Rita K. Kabaso. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You failed to prevent contamination while working in the aseptic production…
- 02
you failed to adequately clean or disinfect the ISO 5 hood and…
This inspection in context
Rita K. Kabaso
18 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCustom RX, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom RX, LLC?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Custom RX, LLC?
Rita K. Kabaso is named on this Form 483, for the inspection of Jul 31 – Aug 15, 2017. Each investigator has a profile showing what they cite most.
When was Custom RX, LLC inspected by FDA?
The inspection ran Jul 31 – Aug 15, 2017, and the Form 483 is dated August 15, 2017.
How do I get the full Form 483 for Custom RX, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.